Wanbury under Lens for Illegal Export of Diabetes Drug

The Indian drug regulators, who were grappling with issues of quality, have a new beast 
to deal with -illegal export of drugs through repackaging by third party sources, a 
menace that adds to the growing number of quality issues for the drug industry.

Mumbai-based Wanbury Ltd, one of the leading active pharmaceutical ingredients 

(API) manufacturers of metformin hydrochloride -a diabetic drug -was caught 

by the MaharashtraFood and Drug Administration for illegally exporting this

drug to Mexico, Brazil, Bangladesh and Pakistan.

The total value of these drugs was worth `47 lakh. Wanbury had export orders

of 650 metric tonnes per month from these countries, but it had the capacity to

manufacture only 300 metric tonnes. However, to overcome this shortage, Wanbury

had outsourced the manufacturing of metformin to a company called Pharmaceutical 

Products of India Ltd (PPIL).

“Wanbury just removed the label of PPIL that did not have any export licence, 

and without doing any processing on the product obtained from it, merely stuck 

its own label -Wanbury -and exported it,“ said Maharashtra FDA in a press note.

Wanbury did not respond to an email query sent by ET, and repeated phone 

calls to the company's MD were unresponsive. Senior officials from the Mahrashtra 

FDA said that this is just the tip of the iceberg and there are several companies that 

are under the regulator's glare for indulging in similar practices. “Both the companies 

formed an unholy alliance which was mutually beneficial, but it could have led to 

disastrous effects on the drug exports of our country, as the Drugs and Cosmetics 

Act treats such exported products as spurious,“ the FDA explained. The investigation

also revealed that records for manufacturing and testing were not maintained by PPIL 

and books were fudged to show as if the entire stock of drugs was

manufactured byWanbury itself.

But despite these findings, the regulator has not yet suspended the manufacturing 

licence of Wanbury as the matter has moved to a different jurisdiction. The investigation 

by the Maharashtra FDA comes at a time when Indian drug companies are battling 

a perception issue of quality in its export markets. The total legal fees that drug 
companies had spent in FY1516 was about `5,000 crore, according to data from ET intelligence.